Prosecution Insights
Last updated: July 17, 2026
Application No. 18/557,550

METHODS AND APPARATUS FOR CLOUD-BASED DATA MANAGEMENT AND REPORTING FOR BIOPROCESS DEVELOPMENT

Non-Final OA §101
Filed
Oct 26, 2023
Priority
Apr 29, 2021 — provisional 63/181,776 +1 more
Examiner
WINSTON III, EDWARD B
Art Unit
3683
Tech Center
3600 — Transportation & Electronic Commerce
Assignee
Cytiva
OA Round
3 (Non-Final)
20%
Grant Probability
At Risk
3-4
OA Rounds
1y 10m
Est. Remaining
51%
With Interview

Examiner Intelligence

Grants only 20% of cases
20%
Career Allowance Rate
74 granted / 372 resolved
-32.1% vs TC avg
Strong +31% interview lift
Without
With
+31.1%
Interview Lift
resolved cases with interview
Typical timeline
4y 7m
Avg Prosecution
26 currently pending
Career history
412
Total Applications
across all art units

Statute-Specific Performance

§101
22.5%
-17.5% vs TC avg
§103
71.1%
+31.1% vs TC avg
§102
4.7%
-35.3% vs TC avg
§112
1.2%
-38.8% vs TC avg
Black line = Tech Center average estimate • Based on career data from 372 resolved cases

Office Action

§101
Notice of Pre-AIA or AIA Status The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . Response to Amendment The following Office action in response to communications received April 20, 2026. Claims 1, 3, 8, 10, 15 and 20 have been amended. Therefore, claims 1-20 are pending and addressed below. Applicant’s amendments to the claims are sufficient to overcome the 35 USC § 103 rejections set forth in the previous office action dated February 20, 2026. Claim Rejections - 35 USC § 101 35 U.S.C. 101 reads as follows: Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title. Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Based upon consideration of all of the relevant factors with respect to the claims as a whole, the claims are directed to non-statutory subject matter which do not include additional elements that are sufficient to amount to significantly more than the judicial exception because of the following analysis: Independent Claim(s) 1, 8 and 15 are directed to an abstract idea comprising systems and methods for collecting data from multiple laboratory sources, linking it to a shared project based on data type, creating and reporting an overlaid chromatogram as part of a bioprocessing step, and enabling collaborative access with change tracking for project data. Independent Claims 1, 8 and 15 substantially recite “initiate/initiating a connection with a local device using a transmission control protocol (TCP) handshake, the local device including at least one of an electronic laboratory notebook (ELN) or a first laboratory device, the ELN including a record associated with at least one of a buffer, a filtration, a chromatogram, a bioreactor, or a batch report; retrieve a first data set from the local device; retrieve a second data set from a second laboratory device; link the first data set and the second data set to a first project, the first data and the second data set linked to the first project based on a type of data in the first data set and the second data set; generate a data overlay using the first data set and the second data set, the data overlay including an overlay of a first chromatogram and a second chromatogram; display the data overlay, the display including a position of the first chromatogram or the second chromatogram in a data collection period; generate a report including the data overlay, the data overlay a result of a bioprocessing step associated with the first project; link the report to the first project, the first project accessible to a first user and a second user associated with the first project; track changes made by the first user and the second user to the first data set or the second data set associated with the report; initiate a second project prior to data retrieval from a third laboratory device to designate data analyses to perform after data retrieval from the third laboratory device, the second project separate from the first project, the second project linked to a cloud-computing platform, the data retrieval from the third laboratory device initiated based on availability of data collected by a collaborator identified by a third user of the second project, the collaborator different from the third user; and prompt an authorization of the third user based on a user identity and data synchronization service, a successful authentication of the third user resulting in a return of tokens to an Application Programming Interface (API) Gateway.” The limitations of Claims 1, 8 and 15, as drafted, under its broadest reasonable interpretation, covers the performance of: Mental processes, including concepts performed in the human mind such as observation, evaluation, judgment, and opinion, because the claim recites retrieving a first data set, retrieving a second data set, linking the first data set and the second data set to a first project based on a type of data, generating a data overlay using the first data set and the second data set, displaying the data overlay including a position of the first chromatogram or the second chromatogram in a data collection period, generating a report including the data overlay, linking the report to the first project, tracking changes made by the first user and the second user to the first data set or the second data set associated with the report, initiating a second project to designate data analyses to perform, and prompting an authorization of the third user so that a successful authentication of the third user results in a return of tokens to an Application Programming Interface (API) Gateway. Certain methods of organizing human activity, including managing relationships, clinical workflows, and project collaboration, because the claim recites linking the first data set and the second data set to a first project, making the first project accessible to a first user and a second user associated with the first project, tracking changes made by the first user and the second user, initiating a second project separate from the first project, linking the second project to a cloud-computing platform, identifying a collaborator by a third user of the second project, and prompting an authorization of the third user based on a user identity and data synchronization service. Mathematical concepts, including calculations, formulas, and model-based computations, because the claim recites generating a data overlay using the first data set and the second data set, the data overlay including an overlay of a first chromatogram and a second chromatogram, and designating data analyses to perform after data retrieval from the third laboratory device, which are mathematical operations applied to the first data set and the second data set. But for the recitation of generic computer components, the claim steps are simply obtaining data from a local device and a second laboratory device, linking the data to a first project, generating and displaying a data overlay, generating a report including the data overlay, linking the report to the first project, tracking changes made by multiple users to the first data set or the second data set, initiating a second project separate from the first project and linked to a cloud-computing platform, and prompting an authorization of a third user so that a successful authentication of the third user results in a return of tokens to an Application Programming Interface (API) Gateway. This judicial exception is not integrated into a practical application. In particular, the claims recite the additional elements of using a “memory, processor circuitry to execute machine readable instructions, local device using a transmission control protocol (TCP) handshake, the local device including at least one of an electronic laboratory notebook (ELN) or a first, second and third laboratory device, a cloud‑computing platform and an Application Programming Interface (API) Gateway” to perform all of the “obtaining, transforming, parsing, determining, transforming, selecting and storing” steps. The “memory, processor circuitry to execute machine readable instructions, local device using a transmission control protocol (TCP) handshake, the local device including at least one of an electronic laboratory notebook (ELN) or a first, second and third laboratory device, a cloud‑computing platform and an Application Programming Interface (API) Gateway” is/are recited at a high-level of generality (i.e., as a generic processor performing a generic computer function of executing computer-executable instructions for implementing the specified logical function(s) such that it amounts no more than mere instructions to apply the exception using a generic computer component. Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not improve the functioning of the system for process data management, the memory, the processor circuitry, the electronic laboratory notebook (ELN), the first laboratory device, the second laboratory device, the third laboratory device, the cloud‑computing platform, or the Application Programming Interface (API) Gateway. The claim instead applies the abstract idea in a conventional computing environment by using a transmission control protocol (TCP) handshake, an electronic laboratory notebook (ELN), a first laboratory device, a second laboratory device, a third laboratory device, a cloud‑computing platform, and an Application Programming Interface (API) Gateway as components for obtaining data, linking data to a first project and a second project, generating a data overlay, tracking changes made by a first user and a second user, and prompting an authorization of a third user. The claim is directed to an abstract idea. Claims 1, 8 and 15 have the following additional elements (i.e., memory, processor circuitry to execute machine readable instructions, local device using a transmission control protocol (TCP) handshake, the local device including at least one of an electronic laboratory notebook (ELN) or a first, second and third laboratory device, a cloud‑computing platform and an Application Programming Interface (API) Gateway). These elements are recited at a high level of generality and merely use generic computer components and laboratory devices to perform generic functions such as initiating a connection using a transmission control protocol (TCP) handshake, retrieving data, linking the data to a first project and a second project, and passing tokens to an Application Programming Interface (API) Gateway. Looking to the specification, these components are described at a high level of generality (see at least ¶ 81 and 102; The example software distribution platform 1805 may be implemented by any computer server, data facility, cloud service, etc., capable of storing and transmitting software to other computing devices.). The use of a general-purpose computer, taken alone, does not impose any meaningful limitation on the computer implementation of the abstract idea, so it does not amount to significantly more than the abstract idea. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements individually. As an ordered combination, the claim recites memory and processor circuitry to execute machine readable instructions to at least initiate a connection with a local device, retrieve a first data set, retrieve a second data set, link the first data set and the second data set to a first project, generate a data overlay, display the data overlay, generate a report including the data overlay, link the report to the first project, track changes made by a first user and a second user, initiate a second project linked to a cloud‑computing platform, and prompt an authorization of a third user so that a successful authentication of the third user results in a return of tokens to an Application Programming Interface (API) Gateway, which is a sequence of abstract data collection, abstract data processing, abstract project management, and abstract authorization steps implemented on generic components. The combination of elements does not indicate a significant improvement to the functioning of a computer or any other technology and their collective functions merely provide a conventional computer implementation of the abstract idea. Furthermore, the additional elements or combination of elements in the claims, other than the abstract idea per se, amount to no more than a recitation of generally linking the abstract idea to a particular technological environment or field of use, as the courts have found in Parker v. Flook. Therefore, there are no limitations in the claims that transform the judicial exception into a patent eligible application such that the claims amount to significantly more than the judicial exception. It is worth noting that the above analysis already encompasses each of the current dependent claims (i.e., claims 2-7, 9-14 and 16-20). Particularly, each of the dependent claims also fails to amount to “significantly more’ than the abstract idea since each dependent claim is directed to a further abstract idea, and/or a further conventional computer element/function utilized to facilitate the abstract idea. Accordingly, none of the current claims implements an element—or a combination of elements—directed to an inventive concept (e.g., none of the current claims is reciting an element—or a combination of elements—that provides a technological improvement over the existing/conventional technology). These information characteristics do not change the fundamental analogy to the abstract idea grouping of “Mental Processes, Certain Methods of Organizing Human Activity, Mathematical Concepts” and, when viewed individually or as a whole, they do not add anything substantial beyond the abstract idea. Furthermore, the combination of elements does not indicate a significant improvement to the functioning of a computer or any other technology. Therefore, the claims when taken as a whole are ineligible for the same reasons as the independent claims. Claims 1-20 are therefore not drawn to eligible subject matter as they are directed to an abstract idea without significantly more. Subject Matter Free of Prior Art Examiner notates below the reasons why the claims overcome the prior art. The limitations most likely to distinguish over the cited combination of Heniford et al. and Scolari et al. are: linking the report to the first project, the first project accessible to a first user and a second user associated with the first project; tracking changes made by the first user and the second user to the first data set or the second data set associated with the report; initiating a second project prior to data retrieval from a third laboratory device to designate data analyses to perform after data retrieval from the third laboratory device, the second project separate from the first project, the second project linked to a cloud-computing platform, the data retrieval from the third laboratory device initiated based on availability of data collected by a collaborator identified by a third user of the second project, the collaborator different from the third user; and prompting an authorization of the third user based on a user identity and data synchronization service, a successful authentication of the third user resulting in a return of tokens to an Application Programming Interface (API) Gateway. Response to Arguments Applicant’s arguments filed November 21, 2025 have been fully considered but they are not persuasive. In the remarks applicant argues: (1) The Rejections Under 35 U.S.C. § 101. Applicant's arguments, filed on April 20, 2026 with respect to the rejections Under 35 U.S.C. § 101 in the remarks, have been considered but are moot in view of the new ground(s) of rejection necessitated by the new limitations added to Claims 1, 8 and 15. Conclusion The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. WO 2014127379 A1; Systems and methods are provided for sample processing. A device may be provided, capable of receiving the sample, and performing one or more of a sample preparation, sample assay, and detection step. The device may be capable of performing multiple assays. The device may comprise one or more modules that may be capable of performing one or more of a sample preparation, sample assay, and detection step. The device may be capable of performing the steps using a small volume of sample. WO 2010086862 A1; The present invention provides an electronic laboratory notebook system and method, for planning a research experiment and recording experimental data in a database. Experimental data, protocol and results, may be retrieved and analyzed using the invention. In one embodiment, the electronic notebook of the invention outputs a pictorial image of experimental samples included in a predetermined experiment. The image may include the concentration of all reagents in a sample, and the location of each sample in the experimental design. In some embodiments, the invention provides budget planning and inventory management, wherein dataflow occurs between various fields allowing automatic depletion of inventory upon performance of an experiment, and allowing preparation of cost estimates for performing an experiment. Any inquiry concerning this communication or earlier communications from the examiner should be directed to EDWARD B WINSTON III whose telephone number is (571)270-7780. The examiner can normally be reached M-F 1030 to 1830. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Morgan can be reached at (571) 272-6773. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /E.B.W/ Examiner, Art Unit 3683 /ROBERT W MORGAN/ Supervisory Patent Examiner, Art Unit 3683
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Prosecution Timeline

Oct 26, 2023
Application Filed
Aug 21, 2025
Non-Final Rejection mailed — §101
Nov 21, 2025
Response Filed
Feb 20, 2026
Final Rejection mailed — §101
Apr 20, 2026
Response after Non-Final Action
May 07, 2026
Request for Continued Examination
May 11, 2026
Response after Non-Final Action
May 22, 2026
Non-Final Rejection mailed — §101 (current)

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Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

3-4
Expected OA Rounds
20%
Grant Probability
51%
With Interview (+31.1%)
4y 7m (~1y 10m remaining)
Median Time to Grant
High
PTA Risk
Based on 372 resolved cases by this examiner. Grant probability derived from career allowance rate.

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